Possible Risks Found in EMC incompliant Medical Devices

EMC risks for medical devices and products may seem far-fetched but are more common than you may think. Nowadays, almost everything we use and do is powered by wired as well as wireless technology. This is what’s considered as smart living. Smart activities can range from communicating using the latest smartphones to treating patients using state-of-the-art medical devices. However, despite all the convenience that the modern technology brings. There are some issues regarding the risk that these devices can affect one’s health and safety. Hence, there are industry standards and policies set for manufacturers to comply before bringing their electric products out to the market. To attempt to eliminate or significantly reduce the EMC risks for medical devices and products. EMC testing is one of the indispensable steps to mitigate associated risks upon operating these devices.

Internationally Adopted Medical EMC Tests

EMC or electromagnetic compatibility testing is a test or set of defined tests. Mandated for almost all products that contain electrical or electronic circuitry. Both wired and wireless powered. The main goal of the test is to limit the products’ EMI (electromagnetic interference) or radiation. And to ensure correct operating functionality. In its intended working environment and thus reduce the EMC risks for medical devices and products for the end user. The set limit is within a range that is compatible with operation side by side with other products of similar composition. This test is adopted in all countries all over the world via established international standards.

Medical devices testing standards for EMC are being followed across geographical regions. There is one for New Zealand and Australia known as the RCM testing. For North America, they call it FCC testing. In Europe, it is called CE testing and in Canada, this test is called IC testing. Compliance with these tests has never been more of utmost necessity than in medical devices, potentially saving lives.

Risks of Medical Equipment without EMC Testing

The EMC risks for medical devices and products from non-compliance become an issue of highest importance. This is due to the result of a certain study. Indicating around 97% of medical devices applying for EMC product certification fail upon the first attempt. These products that never passed the tests were not issued a compliance certificate and were not released to the market. However, it is still alarming to note that if no such tests were required, the market would have been flooded with medical devices. That could potentially bring a lot of harm to their users.

That possibility alone is enough reason to make EMC compliance a “must” step before any electrical product or device is distributed to the market. Together with very strict air-tight enforcement mechanisms. It is difficult to imagine the potential damage if medical devices slip off the radar and hit the market without the EMC seal of approval. The very high value and the life-threatening implications of the use of some medical equipment for medical treatment. Demand a very serious move in enforcing the mandated EMC and safety tests.

Food and Drug Administration (FDA)

The FDA Compliance Centre for Devices and Radiological Health has expressed its very deep concern for the safety of medical devices. In fact, it has issued a memorandum to manufacturers regarding the design of their medical products. The FDA cited several instances where medical devices have been reported to have malfunctioned. Malfunctions due to electromagnetic interference. This includes a wheelchair that suddenly swerved towards moving traffic. A defibrillator that failed to revive a patient and a heart monitor that missed registering a critical reading.

EMC Risks to electromagnetic interference

The EMC risks for medical devices and products are therefore many and real. This is because almost all devices and gadgets are designed with some digital or electronic content in them. Hence, their presence with other digital gadgets. Can mean that there is an electromagnetic compatibility issue within their surroundings. This can affect the devices’ operating efficiency, to say the least. Examples of critical devices used in treatment and diagnostics that can be susceptible to electromagnetic interference include:

• Pacemakers;
• ICDs;
• ECGs; and
• Ventilators

The consequence of EMC Noncompliance

In addition to the heavy risks in the usage of a medical device that does not go through proper EMC testing. The implications of non-compliance for a certain manufacturer involve not only administrative sanctions. But also civil and criminal liabilities. This is true especially if the device would cause undue damage and disadvantage to their users. If the device has caused major and irreparable harm, as in death, to a patient. One can only imagine the stigma that will be attached to that device and its manufacturer.

The EMC certification for every product that a manufacturer produces. Will indicate that the products are safe and reliable. If the devices are meant to provide convenience and make living smarter. The EMC certification will serve as a mark to define the business’ corporate social responsibility.

EMC Bayswater – Reliable EMC Testing Centre

For accurate and reliable results, EMC Bayswater is the preferred company when it comes to EMC testing and approvals. We are the accredited specialists for Australia, Europe, North America, and Canada. Our spacious testing laboratories can accommodate all EMC testing requirements. Including product certification, compliance and approval. For all your EMC testing needs. Whether pre-compliance or formal EMC testing for medical products. Reduce your EMC risks for medical devices and products, trust only EMC Bayswater. For more information about our services, call us at 03 9761 5888.

Possible Risks Found in EMC incompliant Medical Devices was last modified: June 8th, 2018 by EMC Bayswater Pty Ltd